The invention relates to the diagnosis and treatment of sleep disorders. It more particularly relates to the use for this purpose of a device known as “kinesthetic stimulation” device, that is to say a device with external sensory stimulation of the patient by methods of a vibrator in contact with skin in a sensitive, specific area of the body of the patient. Enabling this vibrator has the effect of locally exciting cutaneous endings or mechanical receptors in the skin and triggering a response of the autonomic nervous system of the patient, with sympathetic predominance (hereinafter “autonomic response”).
Autonomic response to sympathetic activation is observable on major modulator effects of cardiac activity, for example:    Chronotropic effect: increased heart rate, or decrease in RR intervals;    Inotropic effect: increased cardiac contractility.
This autonomic response is also observed on the peripheral vasoconstriction, which is increased in case of sympathetic autonomic activation. This phenomenon may be implemented notably with the device described in US 2013/0102937 A1, which proposes to treat hypertension by appropriate stimulation of baroreceptors or nerves, especially during periods when the patient is asleep. The stimulation is triggered when the patient is known to be dormant, then maintained at a constant level. In addition to these effects on cardiac activity, sympathetic activation causes responses in the respiratory system or in the central nervous system (autonomic awakenings).
This is a noninvasive method which is applicable for a number of sleep disorders as an alternative to conventional therapeutic approaches based on the application of a continuous positive airway pressure through a face mask (processing named CPAP), the use of a mandibular protrusion splint and/or electrical stimulation of the hypoglossal nerve, which involves an implant such as a pacemaker.
In particular, the respiratory disease known as “sleep apnea syndrome” (SAS) is characterized by the frequent occurrence (at least 10 to 20 times per hour) of apneas during a sleep phase of the patient, an “apnea” (or pause in breathing) being defined as a temporary cessation of the respiratory function for a duration of more than 10 seconds. It may also be characterized by the occurrence in the same conditions of hypopnea, a “hypopnea” being defined as a significant decrease (but without interruption) of the respiratory rate, typically a decrease of over 50% compared to an earlier reference mean. In the following of the description, we will not distinguish between these two phenomena, a reference to “apneas” being meant to also include hypopneas.
This condition reached more than 4% of the population and over 50% of patients with heart failure. To protect the individual against asphyxiation due to the decrease of oxygen concentration in the blood during the interruption or reduction of the respiratory rate, the body adapts but with a deleterious effect on sleep, causing unconscious micro-awaking. Daytime sleepiness, with loss of attention and increased risk of accident, follows in phase of awakening. Furthermore, several studies of patients with SAS have shown greater incidence of disorders such as arterial hypertension, ventricular arrhythmias, myocardial infarction and heart failure.
For stopping the apnea episodes with a stimulation therapy, US2008/0009915 A1 proposes an acoustic stimulation therapy, US2004/0215236 A1 a vestibular stimulation therapy, WO2009/154458 A1 an electrical stimulation therapy and the U.S. Pat. No. 4,813,427A the application of a gas in parallel to tactile stimulation therapy. Kinesthetic stimulation has been proposed in the past to minimize or stop the episodes of sleep apnea in adults or in the newborn, as described for example in the WO 2007/141345 A1 (FR 2908624 A1).
These techniques are also described in the articles of Pichardo R., et al., “Validation of a Vibrotactile Stimulation System to Treat Apnea of Prematurity”, Proceedings of the IEEE 27th annual Northeast Bioengineering Conference, University of Connecticut, Storrs, Conn. (2001) 13-14, and Beuchée A. et al., “Stimulateur kinesthésique automatisé asservi à la détection d'apnées-bradycardies chez le nouveau-né prématuré”, ITBM-RBM, 28(2007) 124-130.
The first drawback of these stimulation methods is the response variability according to the patient, or even depending on the patient's condition and in particular the sleep state. This variability may require complex initialization methods of the system to adapt to the patient parameters. The second drawback is a phenomenon of habituation, which requires therapy to constantly evolve to keep it effective. Some systems describe a randomized variation of the therapy, which then may be poorly reproducible. The third drawback is the risk of waking the patient. Indeed, the stimuli can generate awakenings in turn responsible for the sleep destructuration. These awakenings induce a loss of much of the benefit of therapy. But few methods take into account this risk, or describe an impractical method for example based on the detection of sleep states by analyzing the EEG, a technique which is impractical in routine practice or at home.